Quality Assurance Specialist
Relocation expenses reimbursed No
Conditions of Employment:
- Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
- E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
- U.S. Citizenship is required for Federal employment.
- Selective Service registration required for certain males based on DOB.
- Background check to determine suitability for Federal employment.
- Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
- Pre-employment physical required: No
- Drug testing required: No
- License required: No
- Mobility agreement required: No
- Immunization required: No
- Bargaining Unit Position: No
- Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
- Financial disclosure statement, OGE-450, required: No
Selective Placement Factor:
One year of regulatory quality assurance experience conducting quality assurance reviews of nonclinical laboratory studies to determine compliance with Food and Drug Administration Good Laboratory Practice regulatory requirements.
Possess a degree with a major study of quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position; (or) possess a combination of graduate education and professional experience. Examples of professional experience includes: Perform audits, evaluations and inspections to verify conformance to Good Laboratory Practice (GLP) compliance regulation; implement policies and standards for the evaluation & monitoring of research; ensure Standard Operating Procedures, (SOP) protocols and audit schedules are adhered to.
Experience reviewing production activities and capabilities in light of contract quality requirements.
Reviewing written quality or inspection procedures for adequacy, and evaluating the implementation and effectiveness of quality/inspection systems, including sampling plans; Analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system.
Verifying by test or inspection, using sampling inspection or intensive product inspection techniques that products comply with requirements prior to acceptance. Identifying inadequacies and requesting corrective action; Computing data, summarizing results, and preparing reports or charts depicting pertinent relationships using statistical methods.
Investigating customer complaints and deficiency reports, and providing identification of causes to appropriate authorities. Reading, interpreting, and applying technical data such as blueprints, engineering drawings, product specifications, or technical manuals; Reviewing and evaluating supply systems operations and procedures through periodic audits and surveillance inspection.
Possess one year of experience, equivalent to at least the GS-9 level in the Federal service, experience includes conducting quality assurance audits to evaluate laboratory operations for compliance with the Food and Drug Administration (FDA) Good Laboratory Practice (GLP) regulations and auditing protocols, raw data, data summary tables and final reports associated with nonclinical laboratory studies to ensure protocol requirements are met and followed by the FDA GLP regulations (or) possess 3 years of progressively higher level graduate education, leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree. This experience must be reflected in your resume. Volunteer experience can be used as qualifying experience.
If you are qualifying based on education, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities, to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.
If you are serving, or have served in the last 5 years (from 03/07/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointees FAQ - OPM
- Veteran's Preference: If you plan to apply for any kind of Veteran Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Veterans Site.
- Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration site.
- Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Disability Employment
- Inter-agency and Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Workforce Restructuring
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes (at 11:59 pm ET on 03/07/2018) a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether or not you are qualified for this particular position.
If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Interview Process: Structured interviews; may be asked scenario-based interview questions concerning core competencies. Method/tools used to evaluate applicants: work samples, conducting a presentation, reference checks, tests may be used.
Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories: Best Qualified, Well Qualified, or Qualified. The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
- Quality Assurance Process Management
- Law & Regulations
- Risk & Opportunity Management
https://apply.usastaffing.gov/ViewQuestionnaire/10145821 Read more Security clearance Q - Nonsensitive